FDA.reportPublic FDA data

Formoterol Fumarate Inhalation Solution

Product NDC
76204-030
11-digit product format
762040030
Labeler code
76204
Product ID
76204-030_459f276c-d771-4ae9-e063-6394a90a3476
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA216486
Marketing category
ANDA
Marketing start
2025-03-14
Substance
FORMOTEROL FUMARATE
Active strength
20 ug/2mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216486-001FORMOTEROL FUMARATEFORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A216486-001AN

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-253bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216486-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2022-11-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216486-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216486-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216486-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216486-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216486-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216486-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216486-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216486-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216486-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216486-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216486-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216486-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216486-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216486-001AN18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216486-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216486-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216486-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216486-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216486-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216486-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216486-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A216486-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A216486-001AN13bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216486-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol Fumarate Inhalation Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMOTEROL FUMARATE20 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W34SHF8J2KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246319Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d9bf685-8886-4865-834b-2748af124b79Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-030-01Formoterol Fumarate Inhalation Solution1 in 1 POUCHSOLUTION13
76204-030-01Formoterol Fumarate Inhalation Solution30 in 1 CARTONSOLUTION303
76204-030-02Formoterol Fumarate Inhalation Solution60 in 1 CARTONSOLUTION603
76204-030-02Formoterol Fumarate Inhalation Solution1 in 1 POUCHSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-030-01ML - Milliliter76204-0307c72c522-0b8f-4caa-b054-2a07e38d1e3312025-05-14
76204-030-02ML - Milliliter76204-0307681015e-c4df-4a55-8eb1-1ecf004ef8a412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-030FORMOTEROL FUMARATE INHALATION SOLUTION (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]2Current NDC, 4 package rows20250315_2d9bf685-8886-4865-834b-2748af124b79.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Formoterol Fumarate Inhalation SolutionFORMOTEROL FUMARATE DIHYDRATERitedose Pharmaceuticals, LLC2d9bf685-8886-4865-834b-2748af124b792025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216486
application number: ANDA216486
ndc (product): 76204-030

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN2d9bf685-8886-4865-834b-2748af124b793
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD2d9bf685-8886-4865-834b-2748af124b793
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY2d9bf685-8886-4865-834b-2748af124b793
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY2d9bf685-8886-4865-834b-2748af124b793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76204-030-017620400300130 POUCH in 1 CARTON (76204-030-01) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL30 pouch2025-03-14NoNoCurrent
76204-030-027620400300260 POUCH in 1 CARTON (76204-030-02) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2025-03-14NoNoCurrent